TraceGains, Inc., 1333 W 120th Ave, #209, Westminster, CO 80234 USA | www.tracegains.com | info@tracegains.

com | 720-465-9400 | @tracegains

Checklist
FDA Audit Checklist: Inspection Day
Know What to Expect, and How to Handle Yourself and Your Team
Its here the day of your FDA Audit Inspection. What can you expect? What should you be prepared for? The FDA Audit
Inspection Day Checklist will help alleviate some of the stress and worry by giving you the information you need to be as
prepared as possible for your next FDA Audit Inspection.
Greet the FDA Auditor and Begin Notifications
Receptionist should notify the Responsible Person.
Responsible Person should notify the remaining members of the Inspection Team.
Remaining employees should be notified gradually and instructed not to speak with the FDA without a
member of the Inspection Team present.
Responsible person should notify the companys legal counsel and request that they are available for
questions, if needed.
Introductions between FDA and Inspection Team, Including Credentials
Receipt of Notice of Inspection Form 482
Keep in mind, it is perfectly OK to ask the FDA if there is any particular reason for the inspection. They may
not tell you. Sometimes they are not permitted to tell you the reason for the inspection, while other times
they are, but in either case it is perfectly acceptable for you to ask.
Initial Walk-Through of the Facility with the Inspection Escort (The responsible person really does not need to
be involved at this stage or during the substantive inspection; however, he or she may choose to be involved.)
The FDA may ask some general questions about the operations, which the inspection escort should be fully
prepared to answer.
Substantive Inspection
SMEs and Responsible Person should be ready and available.
Address FDA Questions During the Inspection
General operations and day-to-day activities: Inspection Escort.
Specific issues (e.g., intake of raw materials that may be considered high risk for contamination): Subject
Matter Experts (SMEs).
Document or Record Requests: Responsible Person.
Use TraceGains to retrieve any requested documents, quickly and easily.
Understand Your Rights with Regard to Requests for Records
Required As the name suggests, these must be handed over to the FDA upon request. You must provide
copies of product labeling if the FDA requests. Most of your records like your manufacturing records or
inventory are only required when the FDA identifies a reasonable risk to consumer safety, specifically, the
FDA has a reasonable basis to believe that the product is adulterated and that it presents a serious threat of
adverse consequences or death. So in that instance, if the FDA has made the determination that that is the
case, and they want to see certain types of records, you are obligated to provide those.
Automated supplier, compliance, and regulatory document management for the food supply chain.
TraceGains, Inc., 1333 W 120th Ave, #209, Westminster, CO 80234 USA | www.tracegains.com | info@tracegains.com | 720-465-9400 | @tracegains
Checklist
FDA Audit Checklist: Inspection Day (continued)
Voluntary These records can be turned over if youd like, and its often in your interest to do that, even if
not required.
Exempt These records are things like formulas, recipes, and financial information. If the FDA wants to get
these and feels there is a need for this information, then they have to get a formal subpoena or a court
order for them
When the FDA does request records, you should ask for:
List of requests for labeling, then provide these ASAP.
List of requests for voluntary records
Form 482c for required records (other than labeling), which is a formal written notice

The rule mandates that you turn over the documents as soon as possible or no more than 24 hours after the request is
made. Its important to have a formal list of all requests, however, so that you have time to review each request and
contact legal counsel for guidance. Ultimately, the Responsible Person will make the final decision about what to
produce.
Keep an inventory and copies of all records provided to the FDA so that no one is left trying to remember what
was given to the FDA and what wasnt.
Closing out the inspection. There will likely be a final meeting to close out the inspection. Both the Responsible
Person and Inspection Escort should attend. SMEs may also attend, as appropriate. Ask questions if you do not
understand the corrective actions, if any, that FDA is requiring or requesting in the Form 483.
Automated supplier, compliance, and regulatory document management for the food supply chain.
Produced in cooperation with Antonio Gallegos, Of Counsel at Greenberg Traurig, LLP, Denver, CO, gallegosa@gtlaw.com